Safety of GH001 in Healthy Volunteers

A Phase 1 Dose-ranging Study of GH001 in Healthy Volunteers

The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers.

The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.

Inclusion Criteria:

• Subject has a body mass index (BMI) in the range of 18.5 and 27.0 kg/m2 (inclusive);
• Subject is in good general health in the opinion of the medical supervisor;
• Subject is in good mental health in the opinion of the (clinical) psychologist as determined by the intake interview;

Exclusion Criteria:

• Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
• Has received any investigational medication within the last 1 month.
• Has a medically significant condition, which renders the subject unsuitable for the study.